AzTrials
AzTrials

Rectal NeoplasmsPhase 1NCT01584544

Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

A Phase 1 study testing capecitabine in people with Rectal Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Rectal Neoplasms
What is being tested?
capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
Jan 2011to May 2014
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
  • KPS status no less than 70; Charlson comorbidity no more than 3.
  • life expectancy more than 6 months.
  • hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
  • do not have allergy history to thymidine phosphorylase.
  • do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
  • no previously pelvic irradiation history
  • informed consent signed

Who cannot join

  • other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
  • previous pelvic irradiation history
  • receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
  • allergy history to thymidine phosphorylase
  • active infection existed
  • severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
  • anticipate other clinical trials in four weeks before enrollment

Trial locations and contacts

1 site in 1 country.

China1 site

  • radiation department, Cancer Hospital, CAMS

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

Read the detailed description

It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility.

Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.

The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.

Being tested
capecitabine
Keywords
rectal neoplasms, aged, chemoradiotherapy, clinical trials, phase I, capecitabine
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabineDrug

    Also called stare 1

    oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

  • CapecitabineDrug

    Also called stare 2

    oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

  • CapecitabineDrug

    Also called stare 3

    oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

  • CapecitabineDrug

    Also called stare 4

    oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

  • CapecitabineDrug

    Also called stare 5

    oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Study groups in NCT01584544
Study groupRoleWhat they receive
1000mgExperimentalcapecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
Receives: Drug: capecitabine
1200mgExperimentalcapecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Receives: Drug: Capecitabine
1350mgExperimentalcapecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Receives: Drug: Capecitabine
1500mgExperimentalcapecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Receives: Drug: Capecitabine
1650mgExperimentalcapecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experienced Dose Limited Toxicity

    Dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment

    Measured: up to 7 weeks from start of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01584544
Sponsor's protocol ID
CH-GI-024
Status last verified
Apr 2015
First submitted
20 Apr 2012
Last updated
20 Apr 2015
Data monitoring committee
Yes

Publications

  • Aapro MS, Kohne CH, Cohen HJ, Extermann M. Never too old? Age should not be a barrier to enrollment in cancer clinical trials. Oncologist. 2005 Mar;10(3):198-204. doi: 10.1634/theoncologist.10-3-198.

    PubMed 15793223

  • Papamichael D, Audisio R, Horiot JC, Glimelius B, Sastre J, Mitry E, Van Cutsem E, Gosney M, Kohne CH, Aapro M; SIOG. Treatment of the elderly colorectal cancer patient: SIOG expert recommendations. Ann Oncol. 2009 Jan;20(1):5-16. doi: 10.1093/annonc/mdn532. Epub 2008 Oct 15.

    PubMed 18922882

  • Potosky AL, Harlan LC, Kaplan RS, Johnson KA, Lynch CF. Age, sex, and racial differences in the use of standard adjuvant therapy for colorectal cancer. J Clin Oncol. 2002 Mar 1;20(5):1192-202. doi: 10.1200/JCO.2002.20.5.1192.

    PubMed 11870160

  • Hemminki K, Santi I, Weires M, Thomsen H, Sundquist J, Bermejo JL. Tumor location and patient characteristics of colon and rectal adenocarcinomas in relation to survival and TNM classes. BMC Cancer. 2010 Dec 21;10:688. doi: 10.1186/1471-2407-10-688.

    PubMed 21176147

  • Janssen-Heijnen ML, Houterman S, Lemmens VE, Louwman MW, Maas HA, Coebergh JW. Prognostic impact of increasing age and co-morbidity in cancer patients: a population-based approach. Crit Rev Oncol Hematol. 2005 Sep;55(3):231-40. doi: 10.1016/j.critrevonc.2005.04.008.

    PubMed 15979890

  • Chang GJ, Skibber JM, Feig BW, Rodriguez-Bigas M. Are we undertreating rectal cancer in the elderly? An epidemiologic study. Ann Surg. 2007 Aug;246(2):215-21. doi: 10.1097/SLA.0b013e318070838f.

    PubMed 17667499

  • Townsley C, Pond GR, Peloza B, Kok J, Naidoo K, Dale D, Herbert C, Holowaty E, Straus S, Siu LL. Analysis of treatment practices for elderly cancer patients in Ontario, Canada. J Clin Oncol. 2005 Jun 1;23(16):3802-10. doi: 10.1200/JCO.2005.06.742.

    PubMed 15923574

  • Ayanian JZ, Zaslavsky AM, Fuchs CS, Guadagnoli E, Creech CM, Cress RD, O'Connor LC, West DW, Allen ME, Wolf RE, Wright WE. Use of adjuvant chemotherapy and radiation therapy for colorectal cancer in a population-based cohort. J Clin Oncol. 2003 Apr 1;21(7):1293-300. doi: 10.1200/JCO.2003.06.178.

    PubMed 12663717

  • Surgery for colorectal cancer in elderly patients: a systematic review. Colorectal Cancer Collaborative Group. Lancet. 2000 Sep 16;356(9234):968-74.

    PubMed 11041397

  • Vulto AJ, Lemmens VE, Louwman MW, Janssen-Heijnen ML, Poortmans PH, Lybeert ML, Coebergh JW. The influence of age and comorbidity on receiving radiotherapy as part of primary treatment for cancer in South Netherlands, 1995 to 2002. Cancer. 2006 Jun 15;106(12):2734-42. doi: 10.1002/cncr.21934.

    PubMed 16703598

  • Devon KM, Vergara-Fernandez O, Victor JC, McLeod RS. Colorectal cancer surgery in elderly patients: presentation, treatment, and outcomes. Dis Colon Rectum. 2009 Jul;52(7):1272-7. doi: 10.1007/DCR.0b013e3181a74d2e.

    PubMed 19571704

  • Law WL, Choi HK, Ho JW, Lee YM, Seto CL. Outcomes of surgery for mid and distal rectal cancer in the elderly. World J Surg. 2006 Apr;30(4):598-604. doi: 10.1007/s00268-005-0442-x.

    PubMed 16568224

  • Endreseth BH, Romundstad P, Myrvold HE, Bjerkeset T, Wibe A; Norwegian Rectal Cancer Group. Rectal cancer treatment of the elderly. Colorectal Dis. 2006 Jul;8(6):471-9. doi: 10.1111/j.1463-1318.2005.00921.x.

    PubMed 16784465

  • Larsen SG, Wiig JN, Tretli S, Giercksky KE. Surgery and pre-operative irradiation for locally advanced or recurrent rectal cancer in patients over 75 years of age. Colorectal Dis. 2006 Mar;8(3):177-85. doi: 10.1111/j.1463-1318.2005.00877.x.

    PubMed 16466556

  • Vironen JH, Sainio P, Husa AI, Kellokumpu IH. Complications and survival after surgery for rectal cancer in patients younger than and aged 75 years or older. Dis Colon Rectum. 2004 Jul;47(7):1225-31. doi: 10.1007/s10350-004-0557-4. Epub 2004 May 28.

    PubMed 15164247

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing capecitabine in people with Rectal Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experienced Dose Limited Toxicity (time frame: up to 7 weeks from start of the treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01584544, which also lists 54 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in