Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Preoperative Short-course Radiotherapy With Local Boost Versus Conventional Preoperative Short-course Radiotherapy for Rectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02498353
• Other study ID #: ZNHCR
• Status: Not yet recruiting
• Phase: N/A
• First received: June 28, 2015
• Last updated: July 10, 2015
• Start date: July 2015
• Est. completion date: May 2020

Study information

• Verified date: July 2015
• Source: Zhongnan Hospital
• Contact: Fuxiang Zhou, professor
• Phone: 8618971252780
• Email: happyzhoufx[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.

Description:

The study plans to recruit 100 patients,randomized into study group and control group,patients in study group are given the dose of PTV(planned target volume)-CTV(clinical target volume) 25Gy/5F with a local boost of PTV-GTV(gross tumour volume) 30Gy/5F；patients in control group are given the dose of PTV-CTV 25Gy/5F without a local boost. The other inventions are the same during the whole treatment,after the radiotherapy,they will receive a surgery under TME((total mesorectal excision) principal.Comparing the toxicity of radiotherapy, R0 resection rate,pathological complete remission rate, complications of operation and sphincter retention rate of these two groups to find out weather local boost bringing benefits to patients with local advanced rectal cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Local advanced rectal cancer (TNM Stage :T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography .

• distance between tumour and anal edge =12cm.

• PS((Performance Status) score 0-2 or Karnofsky score=70.

• liver and kidney functions are normal.

• without any treatment before inclusion.

Exclusion Criteria:

• metastasis

• combined with other severe diseases,such as other kind of cancer ,COPD,myocardial infarction,ect.

• include in other clinical trails.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• preoperative short-course radiotherapy with local boost
Except the clinical target volume(CTV),a gross tumour volume(GTV)is delineated,and give a dose of PTV-GTV:30Gy/5F
• preoperative short-course radiotherapy without local boost
Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F

Procedure:
• TME surgery
both study group and control group received surgery under TME principle after radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

References & Publications (13)

Bujko K, Partycki M, Pietrzak L. Neoadjuvant radiotherapy (5 × 5 Gy): immediate versus delayed surgery. Recent Results Cancer Res. 2014;203:171-87. doi: 10.1007/978-3-319-08060-4_12. Review. — View Citation

Faria S, Kopek N, Hijal T, Liberman S, Charlebois P, Stein B, Meterissian S, Meguerditchian A, Fawaz Z, Artho G. Phase II trial of short-course radiotherapy followed by delayed surgery for locoregionally advanced rectal cancer. Colorectal Dis. 2014 Feb;16 — View Citation

Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50. — View Citation

Guckenberger M, Saur G, Wehner D, Thalheimer A, Kim M, Germer CT, Flentje M. Long-term quality-of-life after neoadjuvant short-course radiotherapy and long-course radiochemotherapy for locally advanced rectal cancer. Radiother Oncol. 2013 Aug;108(2):326-3 — View Citation

Inra JA, Syngal S. Colorectal cancer in young adults. Dig Dis Sci. 2015 Mar;60(3):722-33. doi: 10.1007/s10620-014-3464-0. Epub 2014 Dec 6. Review. — View Citation

Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, Ackland SP, Schache D, McClure B, McLachlan SA, McKendrick J, Leong T, Hartopeanu C, Zalcberg J, Mackay J. Randomized trial of short-course radiotherapy versus long-course chemoradiation — View Citation

Ortholan C, Romestaing P, Chapet O, Gerard JP. Correlation in rectal cancer between clinical tumor response after neoadjuvant radiotherapy and sphincter or organ preservation: 10-year results of the Lyon R 96-02 randomized trial. Int J Radiat Oncol Biol P — View Citation

Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, Rutten H, Pahlman L, Glimelius B, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. The TME trial after a median follow-up of 6 years: increased local control but no surviva — View Citation

Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal — View Citation

Sauer R, Fietkau R, Wittekind C, Rödel C, Martus P, Hohenberger W, Tschmelitsch J, Sabitzer H, Karstens JH, Becker H, Hess C, Raab R; German Rectal Cancer Group. Adjuvant vs. neoadjuvant radiochemotherapy for locally advanced rectal cancer: the German tri — View Citation

Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rödel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the Germ — View Citation

Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with r — View Citation

van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Påhlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 1 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete remission rate		4 weeks after the surgery	Yes
Secondary	disease free survival		From date of randomization until the date of first documented progression,assessed up to 60 months	No
Secondary	sphincter retention rate		4 weeks after the surgery	Yes
Secondary	toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events,CTCAE v3.0)		up to 60 months	Yes