Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT01302613|
Recruitment Status : Terminated (Drug shortage)
First Posted : February 24, 2011
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage II Rectal Cancer Stage III Rectal Cancer||Drug: Capecitabine Drug: 5-FU Drug: Leucovorin Drug: Oxaliplatin Radiation: radiation Procedure: total mesorectal excision||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
RT + Chemo + surgery
Capecitabine will be delivered concurrently with the radiation therapy, at a dose of 1650 mg/m2 divided in even BID doses. It will only be taken on the days of radiation treatment (Monday-Friday, except for holidays). The A.M. dose of the capecitabine must be taken at least one hour prior to the radiation treatment.
5-FU 400 mg/m2, iv bolus on day 1 followed by 2400 mg/m2 iv over 46 hours of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
Leucovorin 400 mg/m2, IV, over 2 hours before 5-FU on day 1 of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
Oxaliplatin 85mg/m2 IV on day 1 of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
28-30 fractions of radiation, given once a day, five days per week (Monday-Friday, except for holidays). The prescribed fraction dose is 180 cGy; the total radiation dose is thus 5040-5400 cGy. The primary treatment fields will be treated with 25 fractions of 180 cGy/fraction with a "boost" of 3-5 fractions of 180 cGy subsequently delivered.
Procedure: total mesorectal excision
Optimal surgical technique involving use of total mesorectal excision (TME) is mandated. The type of surgery, either low anterior resection with sparing of the sphincter mechanism or sphincter-eliminating abdominoperineal resection (APR), will be at the discretion of the attending surgeon.
- The primary study endpoint for the phase I portion of this study is to assess surgical complications through the Clavien grading system. [ Time Frame: 90 days ]The adverse events will be followed prospectively from the date of surgery for 90 days. Dose-limiting toxicity (DLT) will be defined as > grade 3 anastomotic stricture or leak, infection (including pelvic abscess or wound infection), small bowel obstruction, or fistualization. Any other post-operative complication thought related directly to the surgical intervention that is a grade 3 or higher Clavien complication will also be considered dose-limiting toxicity.
- The primary endpoint of the phase II portion of the study is complete pathologic response. [ Time Frame: 9 to 11 weeks ]9 to 11 weeks after the completion of the initial chemoradiotherapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302613
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Jeffrey Meyer, MD||UT Southwestern Medical Center Dallas|