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CONVERT: Neoadjuvant Chemotherapy Alone Versus Preoperative Chemoradiation for Locally Advanced Rectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02288195
Recruitment Status : Active, not recruiting
First Posted : November 11, 2014
Last Update Posted : May 11, 2021
Sponsor:
Collaborators:
Shantou Central Hospital
Liaoning Tumor Hospital & Institute
The First Affiliated Hospital with Nanjing Medical University
Fujian Cancer Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
First Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Guangzhou Medical University
Guangdong Provincial People's Hospital
Cancer Hospital of Guangxi Medical University
Meizhou People's Hospital
Henan Cancer Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Hubei Cancer Hospital
The First Affiliated Hospital of Kunming Medical College
Longyan City First Hospital
Shengjing Hospital
Zhejiang Cancer Hospital
Jiangmen Central Hospital
West China Hospital
The Third Affiliated Hospital of Kunming Medical College.
Information provided by (Responsible Party):
Pei-Rong Ding, Sun Yat-sen University

Brief Summary:
Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could improve overall survival. The purpose of this study is to compare the effects of chemotherapy alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and selective use of the standard treatment to the standard treatment of chemotherapy and radiation.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Drug: Oxaliplatin Drug: capecitabine Radiation: Radiation Phase 3

Detailed Description:

This randomised, open-label, multicentre,phase 3 trial began in August, 2014, as an adjuvant trial comparing capecitabine-based neoadjuvant chemoradiotherapy with chemotherapy alone,in patients aged 18 years to 75 with clinical stage II-III locally advanced rectal cancer from six Chinese institutions.

Patients with local advanced rectal cancer (T2N+ or T3-4aNany,M0, CRM≥2mm, 12cm from the anus verge) were scheduled to Group A: receive neoadjuvant chemotherapy alone (4 cycles of XELOX: oxaliplatin 130mg/m2 day 1,capecitabine 2000mg/m2 days 1-14, repeated every 21 days) followed by radical surgery and 4 cycles of XELOX ( oxaliplatin 130mg/m2 day 1,capecitabine 2000mg/m2 days 1-14, repeated every 21 days) and Group B :chemoradiotherapy (50.4 Gy plus capecitabine 1650 mg/m² administered orally and concurrently with radiation therapy for 5 days per week.) followed by radical surgery and 6 cycles of XELOX ( oxaliplatin 130mg/m2 day 1,capecitabine 2000mg/m2 days 1-14, repeated every 21 days) The primary endpoint was 3-year local recurrence free survival; analyses were done based on all patients with post-randomization data.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 647 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Neoadjuvant Chemotherapy With Capecitabine and Oxaliplatin Versus Chemoradiation for Locally Advanced Rectal Cancer Patients
Study Start Date : August 2014
Actual Primary Completion Date : May 2021
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy
Patients receive neoadjuvant chemotherapy comprising oxaliplatin 130mg/m² ivdrip over 2 hours on day 1,capecitabine 2000 mg/m² on days 1-14, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.Patients without disease progression undergo low-anterior resection (LAR) with total mesorectal excision (TME) and 4 cycles of XELOX ( oxaliplatin 130mg/m² day 1,capecitabine 2000mg/m² days 1-14, repeated every 21 days). Patients with disease progression undergo chemoradiation as in group chemoradiotherapy before proceeding to LAR with TME.
Drug: Oxaliplatin
130 mg/m² iv drip over 2 hours on day 1, repeated every 21 days.
Other Name: Eloxatin

Drug: capecitabine

825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week.

1000 mg/m² po twice daily on days 1- 14 repeated every 21 days in Group A and adjuvant chemotherapy in Group B.

Other Name: Xeloda

Experimental: Chemoradiotherapy
Patients receive capecitabine 825 mg/m² twice daily concurrently with radiation therapy for 5 days per week. Patients also undergo intensity-modulated radiation therapy 5 days a week for approximately 5.5 weeks. Patients then undergo LAR with TME and 4 cycles of XELOX ( oxaliplatin 130mg/m² day 1,capecitabine 2000mg/m² days 1-14, repeated every 21 days) .
Drug: capecitabine

825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week.

1000 mg/m² po twice daily on days 1- 14 repeated every 21 days in Group A and adjuvant chemotherapy in Group B.

Other Name: Xeloda

Radiation: Radiation
The total dosage was 46Gy consisted of 23 fractions of 2 Gy to clinical target volume without a boost dose and with the boost 4 Gy consisted of 2 fractions of 2 Gy to gross tumor volume by IMRT or 3D-CRT.
Other Name: radiotherapy




Primary Outcome Measures :
  1. Time to local recurrence [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: Up to 5 years ]
  2. Pathologic complete response and tumor regression grade [ Time Frame: Up to 18 weeks ]
  3. Pelvic R0 resection rate [ Time Frame: Up to 18 weeks ]
  4. Overall survival [ Time Frame: Up to 5 years ]
  5. Adverse event (AE) profiles [ Time Frame: Up to 5 years ]
  6. Rates of receiving pre-operative or post-operative chemoradiation [ Time Frame: Up to 30 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Diagnosis of rectal adenocarcinoma
  • Radiologically measurable or clinically evaluable disease
  • Tumor location within 12cm from anal verge
  • Clinical stage T2N+ or T3-4aNany,M0 Clinical staging should be estimated based on the combination of the following assessments: physical examination by the primary surgeon, CT scan of the chest/abdomen/pelvis, and a pelvic MRI with or without an endorectal ultrasound (ERUS)
  • No evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on pre-operative MRI
  • No tumor causing symptomatic bowel obstruction
  • No distant metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0, 1
  • White Blood Cell (WBC) ≥ 4,000/mm³
  • Platelets ≥ 100,000/mm³
  • Hemoglobin > 10.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No co-morbid illnesses or other concurrent disease that, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Exclusion Criteria:

  • Pregnant or nursing
  • Patient of child-bearing potential is not willing to employ adequate contraception
  • Not willing to return to enrolling medical site for all study assessments
  • With other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix
  • Chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years)
  • Prior pelvic radiation

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): NCT02288195


Locations
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China, Guangdong
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Shantou Central Hospital
Liaoning Tumor Hospital & Institute
The First Affiliated Hospital with Nanjing Medical University
Fujian Cancer Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
First Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Guangzhou Medical University
Guangdong Provincial People's Hospital
Cancer Hospital of Guangxi Medical University
Meizhou People's Hospital
Henan Cancer Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Hubei Cancer Hospital
The First Affiliated Hospital of Kunming Medical College
Longyan City First Hospital
Shengjing Hospital
Zhejiang Cancer Hospital
Jiangmen Central Hospital
West China Hospital
The Third Affiliated Hospital of Kunming Medical College.
Investigators
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Study Chair: Peirong Ding, MD, Ph D Sun Yat-sen University
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Responsible Party: Pei-Rong Ding, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02288195    
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Keywords provided by Pei-Rong Ding, Sun Yat-sen University:
Neoadjuvant Chemotherapy
Preoperative radiotherapy
Chemoradiotherapy
Capecitabine
Oxaliplatin
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents