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Trial record 2 of 2 for:    hypog | France

Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence (HYPOG-01)

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ClinicalTrials.gov Identifier: NCT03127995
Recruitment Status : Active, not recruiting
First Posted : April 25, 2017
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
UNICANCER

Brief Summary:

The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks.

Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women.

The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments


Condition or disease Intervention/treatment Phase
Breast Cancer Female Radiation: HYPOFRACTIONATED Radiation: NORMOFRACTIONATED Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence
Study Start Date : September 2016
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HYPOFRACTIONATED

40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions per week.

If the patient is candidate for a boost it will be provided as follows:

  • sequential boost with 40 Gy to CTV breast in 15 fractions and 16 Gy to CTV boost in 8 fractions
  • or simultaneous integrated boost (SIB) with 42.3 Gy on CTV breast and 52.2 Gy on CTV boost in 18 fractions
Radiation: HYPOFRACTIONATED
40 Gy/ 15 fractions / 3 weeks
Other Name: Experimental Arm

NORMOFRACTIONATED

50 Gy / 25 fractions, 2.0 Gy per fraction, 5 fractions per week.

If the patient is candidate for a boost it will be provided as follows:

  • sequential boost with 50 Gy to CTV breast in 25 fractions and 16 Gy to CTV boost in 8 fractions
  • or simultaneous integrated boost (SIB) with 51.52 Gy on CTV breast and 63 Gy on CTV boost in 28 fractions
Radiation: NORMOFRACTIONATED
50 Gy/ 25 fractions / 5 weeks
Other Name: Standard Arm




Primary Outcome Measures :
  1. Arm Lymphedema [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Change from baseline ratio of the circumference (cm) of the treated side and contralateral side at week 3 or week 7 of treatment (according the treatment arm and boost realization), and during follow-up (6 months after the last fraction received, every year during 5 years, 10 years)


Secondary Outcome Measures :
  1. Functional Assessment [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Flexion/abduction of the upper arm will be assessed.

  2. Aesthetics Assessment-FIBROSIS [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Fibrosis as tissue induration, telangiectasia, oedema of the breast/chest wall and dyspigmentation will be evaluated according the LENT-SOMA scoring scale.

  3. Aesthetics Assessment-BIS SCORE [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    The patient evaluates satisfaction on The Body Image Score (BIS) where has been added an extra question regarding clothing habits and furthermore based on the study by Lyngholm et al also 2 more questions regarding the satisfaction with the appearance of the treated breast after breast conservation with and without comparison to the opposite breast as done in the DBCG HYPOII trial. In addition, it will ask if the patient treated with breast conservation has had lipo-feeling injection in the breast during follow up.

  4. Aesthetics Assessment-Global Cosmestic [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    The global cosmetic result after breast conservation will be based on Harris´ 4-point scale modified by Rune Gärtner et al

  5. CTCAE Toxicity Assessment [ Time Frame: Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Acute/ late toxicity will be assessed according to the flowchart and performed based on CTCAE V4

  6. RTOG/EORTC Toxicity Assessment [ Time Frame: Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Acute/ late toxicity will be assessed according to the flowchart and performed based on Toxicity Criteria of RTOG/EORTC

  7. Cancer Related events [ Time Frame: 6 months after the last fraction received, every year during 5 years, 10 years ]
    Cancer related endpoints are secondary endpoints in this trial. It's a composite outcome taking into account all relapse events (locoregional, invasive disease, distant disease), breast-cancer specific survival, and causes of death as defined per DATECAN guidelines. All time to cancer related endpoints are defined as starting from the date of randomization until the event.

  8. Cost-Utility [ Time Frame: Week 3 or week 7 of treatment according the treatment arm and boost realization ]
    A cost-utility analysis comparing radiotherapy regimens will be performed based on QALYs

  9. Quality of Life QLQ-C30 [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Patients' quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30

  10. Quality of Life EORTC BR23 [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Patients' quality of life will be assessed using self-administered questionnaire EORTC BR23

  11. Quality of Life Euroqol EQ-5D5D [ Time Frame: Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years ]
    Patients' quality of life will be assessed using self-administered questionnaire Euroqol EQ-5D5D



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman ≥ 18 years who had radical surgery for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of oestrogen receptor, progesterone receptor, malignancy grade, HER2 status.
  • ECOG 0-2
  • Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiotherapy to levels +/-I, +/- II, +/-III, +/-IV, +/-interpectoral nodes (Rötter) and +/-the IMN.
  • Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines are accepted.
  • The patient may be a candidate for a boost to the tumour bed.
  • Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
  • Neoadjuvant chemotherapy for downstaging according to institutional or national guidelines is accepted if there is not an indication for a boost in the area of regional nodes after surgery.
  • Primary systemic therapy of an operable breast cancer is accepted.
  • If the patient is not treated with chemotherapy, the patient must be randomized within 8 weeks from last surgery. If the patient has received adjuvant chemotherapy, the patient must be randomized within 4 weeks after the last series of adjuvant chemotherapy or within 42 days from last surgery in case of surgery after neoadjuvant or adjuvant chemotherapy.Breast implants are accepted.
  • Connective tissue disease is allowed if the treating radiation oncologist finds radiotherapy indicated
  • Postoperative infection and/or seroma giving indication for drainage during RT is accepted
  • Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
  • Signed informed consent
  • Affiliated to the Social Security system

Exclusion Criteria:

  • Previous breast cancer or DCIS of the breast.
  • Bilateral breast cancer
  • Patient with previous non-breast malignancy with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
  • The patient has an indication for boost to 1 or more regional nodes
  • Previous radiotherapy to the chest region
  • Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial
  • Pregnant or lactating
  • Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating radiation oncologist thinks the patient should not participate in the trial for example due to language problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127995


Locations
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Sponsors and Collaborators
UNICANCER
National Cancer Institute, France
Investigators
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Principal Investigator: Sofia RIVERA, M.D, Ph.D Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03127995    
Other Study ID Numbers: UC-0107/1604
2016-A00702-49 ( Other Identifier: Id-RCB )
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
Breast Cancer pT1-3, pN0-N3, M0
Lymph Node Irradiation
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases