Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

• ClinicalTrials.gov Identifier: NCT03702985
• Recruitment Status: Unknown
• First Posted: October 11, 2018
• Last Update Posted: January 23, 2019
• Sponsor: Fudan University
• Information provided by (Responsible Party): Zhu Ji, Fudan University

Study Description

Brief Summary:

The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.

Condition or disease	Intervention/treatment	Phase
Locally Advanced Rectal Cancer	Radiation: Radiation; Drug: Capecitabine; Drug: Irinotecan; Drug: Amifostine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
• Actual Study Start Date: May 28, 2018
• Estimated Primary Completion Date: November 1, 2019
• Estimated Study Completion Date: March 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Capecitabine and Irinotecan without Amifostine; Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.	Radiation: Radiation; Pelvic Radiation: 50Gy/25Fx; Drug: Capecitabine; 625mg/m2 bid Monday-Friday per week; Other Name: Xeloda; Drug: Irinotecan; 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Experimental: Capecitabine and Irinotecan with Amifostine; Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) Amifostine: 400mg/m2 per week Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.	Radiation: Radiation; Pelvic Radiation: 50Gy/25Fx; Drug: Capecitabine; 625mg/m2 bid Monday-Friday per week; Other Name: Xeloda; Drug: Irinotecan; 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7); Drug: Amifostine; 400mg/m2 per week

Outcome Measures

Primary Outcome Measures :

1. the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 [ Time Frame: during neoadjuvant chemoradiation. ]

Secondary Outcome Measures :

1. Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire [ Time Frame: during neoadjuvant chemoradiation. ]
2. pathological response rate [ Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation. ]
3. the morbidity of late radiation proctitis [ Time Frame: late radiation proctitis is measured 9 months after the end of chemoradiation. ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• pathological confirmed adenocarcinoma
• clinical stage T3-4 and/or N+
• the distance from anal verge less than 12 cm
• without distance metastases
• performance status score: 0~1
• UGT1A1*28 6/6 or 6/7
• without previous anti-cancer therapy
• sign the inform consent

Exclusion Criteria:

• pregnancy or breast-feeding women
• serious medical illness
• baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
• DPD deficiency
• UGT1A1*28 7/7

Contacts and Locations

Contacts

Contact: Ji Zhu, MD; +86-2164175590 ext 81607; leo.zhu@126.com

Locations

China, Shanghai

Fudan University Shanghai Cancer Center; Recruiting

Shanghai, Shanghai, China, 200032

Contact: Ji Zhu, MD leo.zhu@126.com

Principal Investigator: Zhen Zhang, MD

Sub-Investigator: Ji Zhu, MD

Sponsors and Collaborators

Fudan University

Investigators

• Principal Investigator: Zhen Zhang, MD; Fudan University

More Information

• Responsible Party: Zhu Ji, professor, Fudan University
• ClinicalTrials.gov Identifier: NCT03702985
• Other Study ID Numbers: FDRT-R007
• First Posted: October 11, 2018
• Last Update Posted: January 23, 2019
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Zhu Ji, Fudan University:

Neoadjuvant Chemoradiotherapy; amifostine; irinotecan; capecitabine

Additional relevant MeSH terms:

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; Irinotecan; Amifostine; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs